Virtual Reality and Concept of Control in the Treatment of Acrophobia

Phobic Disorders Clinical Trial

— CTRLSTRESS  

Official title:

Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02020824
• Other study ID #: CTRLSTRESS
• Secondary ID: 2013-A01280-45 I
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2013
• Last updated: October 29, 2015
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2015
• Source: Qualissima
• Contact: Eric MALBOS, MD
• Phone: 0491746287
• Email: eric.malbos[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia or acrophobia, since it permits to have a better control (on occurrence of events or on the environment) during the therapy than in "in vivo" therapy. Our hypothesis here is that we can improves the therapeutic effects of the virtual exposure by giving control to acrophobic patients during their exposure.

Description:

The study is based on the exposure of acrophobic patients to virtual environments. During the study, several groups of patients will be distributed according to different conditions: exposure to anxiogenous virtual environments and exposure with the ability to control and secure the anxiogenous virtual environments.

The interest of this project is to improve therapy by exposure to virtual reality. Our project offers a systematic therapeutic approach (using virtual reality and the concept of control) where current therapy are too often approximate. We aim to demonstrate the effectiveness of the control of virtual environments on symptomatic and psychophysiological levels, to evaluate the adoption of these methods in the couple patients-caregivers and also to understand the brain mechanisms (including those prefrontal) involved in this therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria of all subjects:

• 18 to 60 years old

• Male or female

• All subjects will be fluent in French.

• Fully informed and freely given, signed Informed consent in written form.

• Patient / Subject affiliated or beneficiary of a social/health security insurance.

Inclusion criteria for acrophobic patients:

• Patients not hospitalized suffering from acrophobia (according to DSM-IV, APA 2000).

• Patients receiving pharmacotherapy (anxiolytics, hypnotics, etc.) may be included provided they are stabilized on treatment for at least 8 weeks.

• Score inferior to 6 at the Behavioural Avoidance Test

Inclusion criteria for healthy volunteers:

• People not hospitalized showing no sign of acrophobia.

• Score superior or equal to 10 at the Behavioural Avoidance Test.

Exclusion Criteria for all subjects:

• Pregnant woman (urine and blood ß -HCG test) or lactating (contraindication to PET-scan).

• Women of childbearing potential without effective contraception (contraindication to PET-scan).

• Subject participating in another research evaluating other treatments including a period of exclusion still ongoing.

• Persons under guardianship and adults subject submitted to a measure of legal protection or unable to consent.

• Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8 and admitted to a health or social institution for purposes other than research.

• People with a non-stabilized diabetes (contraindication to PET-scan).

• Addictions to alcohol or drugs.

• Persons suffering from claustrophobia.

• Contraindications to fMRI.

• People with hearing loss.

• Strong visual impairment (> 5 diopters) not corrected by contact lenses.

Exclusion criteria for acrophobic patients:

• Patients continuing psychotherapy.

• Patients suffering from other neurological disorders or comorbid psychiatric diseases than acrophobia.

• Patients suffering from severe organic disorders that could disable or disrupt the therapeutic process.

• The concomitant drugs at inclusion should not be modified or discontinued during the study.

• No psychotherapy should be initiated during the study.

Exclusion criteria for healthy volunteers:

• Subjects with a known psychiatric or neurological disorders, diagnosed for depression, with emotional disorders affecting their perception of the environment, or taking a medication that may affect the auditory and visual perception, concentration or emotions.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders

Intervention

Behavioral:
• Exposure to anxiogenous environments
The anxiogenous environments are defined by several levels of possible anxiety classified progressively and independently by each patient at the beginning of the study. The exposure is applied during the 8 sessions for each of the arms "Exposure to anxiogenous environments (with or without control)".

Other:
• Imagery with functional MRI initial
Subjects will be submitted to 1 session of fMRI during their first visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
• Imagery with PET-scanner initial
Subjects will be submitted to 1 session of PET-scanner during their first visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.
• Imagery with functional MRI final
Patients will be submitted to 1 session of fMRI during a follow-up visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
• Imagery with PET-scanner final
Patients will be submitted to 1 session of PET-scanner during a follow-up visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.

Locations

Country	Name	City	State
France	Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Qualissima	France: Centre National de la Recherche Scientifique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural Avoidance Test (BAT)	Objective measure of behavior scored on 10 points in response to a virtual environment representing a situation feared by acrophobic patients. This virtual environment is a flat landscape with a platform overlooking a canyon of 800 meters.	1 year (4 times)	No
Secondary	Brain activity (functional MRI)	Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity)	12 weeks (2 times)	No
Secondary	Synaptic activity (PET-scan)	Metabolic and functional : synaptic activity with PET scanner	12 weeks (2 times)	No
Secondary	Cognitive measurements	Attentional bias (DOT test)	12 weeks (2 times)	No
Secondary	Cognitive measurements	Emotional valence (emotional congruence task)	12 weeks (2 times)	No
Secondary	Cognitive measurements	Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)	1 year (4 times)	No
Secondary	Cognitive measurements	Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)	1 year (4 times)	No
Secondary	Cognitive measurements	Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)	1 year (4 times)	No
Secondary	Cognitive measurements	Questionnaire on depression (BDI: Beck Depression Inventory)	1 year (4 times)	No
Secondary	Quality of life	Quality of Life (SF-12: Medical Outcome Study Short Form)	1 year (4 times)	No
Secondary	Cognitive measurements	During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)	10 weeks (8 times)	No
Secondary	Cognitive measurements	During the 8 sessions of exposure to virtual reality: Progression recorded and time to progression from one environment to another during sessions (number of environments completed, time of execution, others ..)	10 weeks (8 times)	No
Secondary	Ergonomy	During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence).	10 weeks (8 times)	No
Secondary	Psychophysiological	During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate)	10 weeks (8 times)	No
Secondary	Adverse events	Assessment and description of all the occurrence of adverse events during the study.	1 year	Yes